Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)

Hypertrophic Clinical Trial

— IMPROVE  

Official title:

Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430130
• Other study ID #: CA005
• Status: Completed
• Phase: N/A
• First received: September 6, 2011
• Last updated: November 21, 2014
• Start date: September 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2014
• Source: Neodyne Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.

Description:

It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The scar to be revised is:

• at least 12 months old

• linear and suitable for revision by excision and direct closure

• appropriate size and location for Neodyne Dressing

• The subject:

• age > 18 and < 65 years old

Exclusion Criteria:

• Subjects with a skin disorder that is chronic or currently active.

• Subjects who are involved in ongoing litigation in connection with the scar to be revised.

• Subjects with a history of collagen vascular disease

• Subjects diagnosed with scleroderma

• Subject who currently smokes

• Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives

• Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.

• Subjects with inability to maintain adequate care of incision.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertrophic

Intervention

Device:
• embrace device
Adhesive bandage/dressing intended to minimize scar formation.

Locations

Country	Name	City	State
United States	Duet Plastic Surgery	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Neodyne Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.; [1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.	6 months	No
Secondary	Subject and Investigator Satisfaction With the Aesthetic Results		Up to 12 months	No
Secondary	Ease of Use		Up to 12 months	No
Secondary	Comfort Level Related to Study Device Application, Wear and Removal		Up to 12 weeks	No
Secondary	Comparison of Scar Smoothness of Treated Side as Compared to the Control Side		Up to 12 months	No